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Analgesic Control Following Knee Arthroscopy

NCT ID: NCT01169389

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

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This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy.

Detailed Description

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There is increasing evidence of the toxic effects of intraarticular administration of local anaesthetic. Hyaluronic acid supplementation given at the time of knee arthroscopy has not been fully evaluated as a possible alternative. We have studied the efficacy of a hyaluronic acid (HA) supplement (Durolane®) and a local anaesthetic (Bupivacaine) at providing early and short-term post-operative analgesic control following knee arthroscopy.Patients will be randomised to receive either 10mls of 0.5% Bupivacaine or 10mls of Durolane® into the joint immediately after completion of surgery. WOMAC and Tegner-Lysholm scores were obtained at baseline then at 1, 2, and 6-weeks post surgery. VAS pain scores were obtained at baseline; 1 and 24-hours; and 1, 2 and 6 weeks following surgery.

Conditions

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Knee Arthroscopy Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Durolane

Group Type ACTIVE_COMPARATOR

Intraarticular injection

Intervention Type PROCEDURE

Durolane, one vial

Bupivacaine

Group Type PLACEBO_COMPARATOR

Intra-articular injection of 0.5% Bupivacaine

Intervention Type PROCEDURE

Interventions

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Intraarticular injection

Durolane, one vial

Intervention Type PROCEDURE

Intra-articular injection of 0.5% Bupivacaine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy
* age over 18 years

Exclusion Criteria

* American Society of Anaesthesiologists (ASA) grade ≥3;
* arthroscopic assisted osteotomies;
* a history of two or more prior procedures on the ipsilateral knee;
* post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE);
* systemic steroid requirements;
* previous intra-articular anaesthetic or steroid injection within the last three months;
* intra-articular HA injection within the last nine months;
* intra-articular sepsis within the previous three months;
* prior history of knee arthroplasty, peri-articular fracture, ligamentous instability, inflammatory arthritis or a previous diagnosis of Complex Regional Pain Syndrome.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orthopaedic Research and Innovation Foundation, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Orthopaedic Research and Innovation Foundation

Principal Investigators

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Kevin J Mulhall, FRCSI

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Research and Innovation Foundation, Ireland

Locations

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Sports Surgery Clinic

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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KM/10/2008/18

Identifier Type: -

Identifier Source: org_study_id